Regulatory Affairs Director jobs in Elkhart, IN
Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Director jobs
- Zimmer Biomet
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Warsaw, IN
FULL_TIME
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At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.
How You'll Create Impact- Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process.
- Author and publish electronic submissions.
- Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates.
- Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
- Provide regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
- Evaluate risk of proposed regulatory strategies and offers solutions.
- Review proposed labeling for compliance with applicable US and international regulations.
- Write, manage, and approve the development of package inserts.
- Review, evaluate, and approve promotion and advertising material for compliance with applicable regulations.
- Review proposed product changes for impact on regulatory status of the product.
- Follow Zimmer Biomet regulatory affairs policy and procedures.
- May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.
- Communicate with regulatory and governmental agencies.
Your BackgroundRequires a Bachelor’s degree in Regulatory Affairs, Engineering, or Life Sciences, or related field.
Requires 5 years of experience in the job offered or a related role.
Must have 3 years of experience in orthopaedic or medical device industry.
Must have 3 years of experience with FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU.
Must have 2 years of experience working with medical products and advanced anatomic knowledge.
Must have 2 years of experience with Interpreting and applying FDA regulations to business practices and providing regulatory input, advice, and guidance to the organization and design teams.
Travel ExpectationsPosition permits remote work throughout the U.S. Position requires up to 15% domestic travel.
EOE/M/F/Vet/Disability - Just Posted
- OrthoPediatrics
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Warsaw, IN
FULL_TIME
- GENERAL SUMMARY : This position is responsible for managing medical device labeling projects and workstreams (including, but not limited to product labels, package inserts / IFUs, patient cards, trans...
- Just Posted
- Instrumedical Technologies, Inc.
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Warsaw, IN
PART_TIME
- Company Overview:Instru-Med is a leading contract manufacturer operating in accordance with ISO 13485 standards. We specialize in providing high-quality manufacturing solutions for medical devices. Ou...
- 30 Days Ago
- The Waters of Syracuse
-
Goshen, IN
FULL_TIME
- THE WATERS OF SYRACUSE IS NOW HIRING FOR DIRECTOR OF NURSING (DON) **SUBSTANTIAL WAGE INCREASE** *PayActiv* A comprehensive benefit package includes: Excellent Pay Tuition Reimbursement Flexible Sched...
- 16 Days Ago
- Infinity Healthcare Consulting
-
La Grange, IN
FULL_TIME
- Now hiring for Activity Director Full Time - Activity Director Duties and Responsibilities: Planning, organizing, developing and directing the overall operation of the Activity Department in accordanc...
- 19 Days Ago
- Infinity Healthcare Consulting
-
Wakarusa, IN
FULL_TIME
- Now Hiring Maintenance Director!! WHAT'S IN IT FOR YOU: Excellent Pay Tuition Reimbursement Paid Holidays including Birthdays Vacation and Sick Time Access to Pay prior to Pay Day Group Health / Denta...
- 20 Days Ago
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0 Regulatory Affairs Director jobs found in Elkhart, IN area
- Lippert Components Inc.
-
Elkhart, IN
- OverviewWho We Are:Lippert is a leading, global manufacturer and supplier of highly engineered products and customized s...
- 4/24/2024 12:00:00 AM
- Beacon Health System
-
South Bend, IN
- Full-time 714 N. Michigan Street Physician Day Reports to the Practice Manager. Is responsible for developing, revising,...
- 4/24/2024 12:00:00 AM
- Lippert Components
-
Goshen, IN
- Overview Who We Are: Lippert is a leading, global manufacturer and supplier of highly engineered products and customized...
- 4/23/2024 12:00:00 AM
- Beacon Health System
-
South Bend, IN
- Full-time 615 N. Michigan Street Clerical Day Reports to the Manager or Director. Is responsible for the coordination of...
- 4/22/2024 12:00:00 AM
- Bonnell Aluminum
-
Niles, MI
- We are seeking an experienced and dedicated EHS Manager to lead our efforts in maintaining the highest stands of environ...
- 4/22/2024 12:00:00 AM
- Bonnell Aluminum
-
Niles, MI
- We are seeking an experienced and dedicated EHS Manager to lead our efforts in maintaining the highest stands of environ...
- 4/21/2024 12:00:00 AM
- Beacon Health System
-
South Bend, IN
- Part-time 615 N. Michigan Street Nursing Support Night Reports to the Director, Patient Care Services. Receives guests, ...
- 4/20/2024 12:00:00 AM
- Andrews University
-
Berrien Springs, MI
- CHILDRENS LEARNING CENTER - Substitute Caregiver Job Classification Hourly Under Half (<20) Position summary We are look...
- 4/20/2024 12:00:00 AM
About Elkhart, Indiana
were up 1.3% from a year ago